Product Manual

COVID-19 Antigen Home Test
Package Insert
for Healthcare Providers
REF L031-118B5 REF L031-125M5 REF L031-125N5 REF L031-125P5 English
A rapid test for the detection of SARS-CoV-2 nucleocapsid antigens in anterior nasal swab specimens.
For in vitro diagnostic use only. For Emergency Use Authorization only.
INTENDED USE
The Flowflex COVID-19 Antigen Home Test is a lateral flow chromatographic immunoassay intended for the
qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nasal swab specimens
directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological
reasons to suspect COVID-19 infection. This test is authorized for non-prescription home use with self-
collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-
collected anterior nasal samples directly from individuals aged 2 years or older. The Flowflex COVID-19
Antigen Home Test does not differentiate between SARS-CoV and SARS-CoV-2
Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen. This antigen is generally
detectable in anterior nasal swabs during the acute phase of infection. Positive results indicate the presence
of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to
determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses.
The agent detected may not be the definite cause of disease.
Individuals who test positive should self-isolate and consult their doctor as additional testing may be
necessary and for public health reporting.
Negative results are presumptive, and confirmation with a molecular assay, if necessary for patient
management, may be performed. Negative results do not rule out SARS-CoV-2 infection and should not be
used as the sole basis for treatment or patient management decisions, including infection control decisions.
Negative results should be considered in the context of an individual’s recent exposures, history and the
presence of clinical signs and symptoms consistent with COVID-19.
Individuals should provide all results obtained with this product to their doctor or healthcare provider for public
health reporting. Doctors or healthcare providers will report all test results they receive from individuals who
use the authorized product to relevant public health authorities in accordance with local, state, and federal
requirements using appropriate LOINC and SNOMED codes, as defined by the Laboratory In Vitro
Diagnostics (LIVD) Test Code Mapping for SARS-CoV-2 Tests provided by CDC.
The Flowflex COVID-19 Antigen Home Test is intended for self-use or lay user testing another in a non-
laboratory setting. The Flowflex COVID-19 Antigen Home Test is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
SUMMARY AND EXPLANATION
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease.
Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic
infected people can also be an infectious source. Based on the current epidemiological investigation, the
incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry
cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.
PRINCIPLE
The Flowflex COVID-19 Antigen Home Test is a qualitative membrane based chromatographic immunoassay
for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in human anterior nasal
swab specimens.
When specimens are processed and added to the test cassette, SARS-CoV-2 antigens, if present in the
specimen, will react with the colored anti-SARS-CoV-2 antibody-coated particles, which have been pre-
coated on the test strip. The antigen-antibody complex then migrates toward the membrane by capillary action.
This complex is then captured by anti-SARS-CoV-2 monoclonal antibodies immobilized at the test line region,
and a colored line appears on the membrane. Test results are interpreted visually at 15-30 minutes based on
the presence or absence of visually colored lines.
To serve as a procedure control, a red line will always appear in the control line region after proper volume of
specimen has been added, and membrane wicking has occurred.
REAGENTS
The test cassette contains anti-SARS-CoV-2 antibodies.
PRECAUTIONS
 Read the COVID-19 Antigen Home Test Package Insert carefully before performing a test. Follow
directions for use. Failure to follow directions may produce inaccurate test results.
 For in vitro diagnostic use.
 This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.
 This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other
viruses or pathogens.
 The emergency use of this product is only authorized for the duration of the declaration that circumstances
exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of
COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-
3(b)(1), unless the declaration is terminated, or authorization is revoked sooner
.
 This product has been designed only for the detection of SARS-CoV-2 antigen, not for any other viruses
or pathogens.
 Inadequate or inappropriate sample collection may yield false test results.
 To obtain accurate results, the test must be performed as indicated in this Instructions for Use.
 INVALID RESULTS, indicated by no Control Line, can occur when an insufficient volume of sample
solution is added to the test device. Gently squeeze the tube and dispense 4 drops of solution into the
sample well of test device.
 Swabs in the kit are approved for use with Flowflex COVID-19 Antigen Home Test. Do not use other swabs.
 Do not use on anyone under two years of age. Keep test kit and materials out of the reach of children and
pets, before and after use.
 Do not open the kit contents until ready to use. If the test cassette is open for an hour or longer, invalid
test results may occur.
 Do not use the test after the expiration date shown on the test cassette pouch.
 Do not use the test if the pouch is damaged or open.
 Do not reuse any kit components. Do not use with multiple specimens.
 Make sure there is sufficient light when reading and interpreting test results.
 Do not use nasal sprays for at least 30 minutes before collecting a nasal sample.
 Remove any piercings from the nose before starting the test. Do not use on anyone who is prone to
nosebleeds or has had facial injuries or head injuries/surgery in the past six months.
 Inadequate or improper nasal swab sample collection may result in false negative test results.
 Do not touch the swab head when handling the swab.
 Test samples immediately after collection, and no more than one hour after the swab is added to the
reagent solution, if stored at room temperature.
 The test is intended to be read at 15 minutes. If the test is read before 15 minutes or after 30 minutes,
false negative or false positive results may occur, and the test should be repeated with a new test cassette.
 Avoid exposure of your skin, eyes, nose, or mouth to the solution in the extraction tube.
 Do not ingest any kit components.
 The reagent solution in the tube contains hazardous ingredients (see table below). If the solution contacts
the skin or eye, flush with plenty of water. If irritation persists, seek medical advice.
https://www.poison.org/contact-us or 1-800-222-1222
Hazardous Ingredients for the Reagent Solution
Chemical Name/
Concentration
Harms (GHS) code for each ingredient Concentration
TX-100 Acute toxicity, Oral (Category 4), H302 Skin irritation (Category
2), H315
Serious eye damage (Category 1), H318 Short-term (acute)
aquatic hazard (Category 1), H400
Long-term (chronic) aquatic hazard (Category 1), H410
1%
Sodium Azide Acute toxicity, Oral (Category 2), H300 Acute toxicity, Dermal
(Category 1), H310 Specific target organ toxicity - repeated
exposure, Oral (Category 2), Brain, H373 Short-term (acute)
aquatic hazard (Category 1), H400
Long-term (chronic) aquatic hazard (Category 1), H410
0.02%
If INHALATION: Move to fresh air. If not breathing, give artificial respiration. Do not use mouth-to-mouth
method if victim ingested or inhaled; give artificial respiration with the aid of a pocket mask equipped with a
one-way valve or other proper respiratory medical device. Immediate medical attention is required.
If SKIN Contact: Take off immediately all contaminated clothing. Wash off immediately with plenty of water
for at least 15 minutes. Immediate medical attention is required.
If EYE Contact: Immediately flush eyes with plenty of water for at least 15 minutes. Assure adequate flushing
by separating the eyelids with fingers. Get medical attention immediately.
If INGESTION: Clean mouth with water. Do not induce vomiting. Risk of aspiration! Keep airways free.
Pulmonary failure possible after aspiration of vomit. Call a physician or Poison Control Center immediately.
STORAGE AND STABILITY
 The kit can be stored at temperatures between 36-86°F (2-30°C).
 The test is stable until the expiration date printed on the sealed pouch.
 The test must remain in the sealed pouch until use.
 DO NOT FREEZE.
 Do not use after the expiration date.
MATERIALS
Materials Provided
 Test Cassettes  Extraction Buffer Tubes
 Disposable Nasal Swabs  Package Insert
 Tube Holder (only for 25 test quantity)
Note: This test comes in a 1 test (REF: L031-118B5), 2 test (REF:
L031-125M5), 5 test (REF: L031-125N5),
25 test (REF: L031-125P5) quantity. The number of items supplied in the kit will vary depending on which kit
was purchased.
Materials Required But Not Provided
 Timer
SPECIMEN COLLECTION AND PREPARATION
 The Flowflex COVID-19 Antigen Home Test is performed using anterior nasal swab specimens.
 Wash or sanitize your hands. Make sure they are dry before starting the test.
 To collect an anterior nasal swab sample:
1. Gently insert the entire absorbent tip of the swab head into 1 nostril (½ to ¾ of an inch). With children, the
maximum
depth of insertion into the nostril may be less than ¾ of an inch, and you may need to have
a
second person to hold the child’s head while swabbing.
Note: A false negative result may occur if the nasal swab specimen is not properly collected.
2. Firmly rub the swab in a circular motion around the inside wall of the nostril 5 times. Take approximately
15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present onto the
swab. Repeat this in the other nostril using the same swab.
3. Remove the swab from the nostril and place into the extraction buffer tube.
DIRECTIONS FOR USE
1. Punch through the perforated circle on the kit box to form a tube holder. For 25 test quantity kit box the
tube holder is included.
2.
Remove the foil from the top of the extraction buffer tube. Place the tube in the tube holder.
3. Immediately place the swab into the tube and swirl for 30 seconds.
4. Rotate the swab 5 times while squeezing the tube.
5. Remove the swab while squeezing the tube to extract as much liquid as possible. Dispose the swab in
the trash.
6. Attach the dropper tip firmly onto the tube. Mix thoroughly by swirling or flicking the bottom of the tube.
Note: A false negative result may occur if the swab is not swirled at least 30 seconds or rotated 5
times.
7. Gently squeeze the tube and dispense 4 drops of solution into the Sample Well. Dispose the tube in the
trash.
Note: A false negative or invalid result may occur if less than 4 drops of fluid are added to the
Sample Well.
8.
Set the timer for 15 minutes. Result should be read at 15 minutes. Do not read after 30 minutes. Dispose
the test cassette in the trash.
Note: A false negative or false positive result may occur if the test result is read before 15 minutes
or after 30 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
NEGATIVE: Only one red control line appears in the control line region (C). No apparent red line appears in
the test line region (T). This means that no SARS-CoV-2 antigen was detected. However, a negative result
does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management
decisions, including infection control decisions. The amount of antigen in a sample may decrease as the
duration of illness increases. Negative results should be treated as presumptive and confirmed with a
molecular assay, if necessary, for patient management.
POSITIVE:* Two distinct red lines appear. One red line in the control line region (C) and the other red line in
the test line region (T). This means that the presence of SARS-CoV-2 antigen was detected, and the patient
is very likely to be infected with the virus and presumed to be contagious. Test results should always be
considered in the context of clinical observations and epidemiological data (such as local prevalence rates
and current outbreak/epicenter locations) in making a final diagnosis and patient management decisions.
Patient management should follow current CDC guidelines.
* NOTE: The intensity of the red color in the test line (T) may vary depending on the level of the SARS-CoV-
2 antigen present in the specimen. Therefore, any shade of red in the test line region (T) should be considered
positive.
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect operation are the most likely
reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the
problem persists, call [phone] for assistance.
QUALITY CONTROL
Internal procedural controls are included in the test. A red line appearing in the control line region (C) is an
internal procedural control. The appearance of the procedural control line indicates that proper volume of
specimen has been added and capillary flow occurred. If the procedural control line does not develop in 15
minutes, the test result is considered invalid, and retesting with a new cassette is recommended.
Swirl for 30
seconds
Rotate at least 5
times while
squeezing the tube
15 min. Negative Positive Invalid